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Progenity (PROG) Investor Presentation
2021-09-17 18:58
/ ® CORPORATE PRESENTATION September 2021 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presentation, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "ob ...
Biora Therapeutics(BIOR) - 2021 Q2 - Earnings Call Transcript
2021-08-13 03:12
Financial Data and Key Metrics Changes - The company reported a revenue of $18.7 million in Q2 2021, with $8.6 million coming from discontinued operations [28] - Total operating expenses were $46 million in Q2 2021, expected to decrease to less than $25 million by Q4 2021 [29][30] - A significant reduction of $97 million in annual operating expenses run rate has been achieved, with an additional $50 million expected by the end of Q4 2021 [22][27] Business Line Data and Key Metrics Changes - The company is transitioning away from molecular testing operations, which will alter its revenue profile [27] - The focus is now on managing cash burn and optimizing capital allocation towards the innovation pipeline [27] - The Oral Biotherapeutics Drug System (OBDS) and Drug Delivery System (DDS) platforms are prioritized for development, with promising initial data from preclinical studies [10][14] Market Data and Key Metrics Changes - The market for oral delivery solutions is estimated at $250 billion, with the company targeting the inflammatory bowel disease (IBD) market valued at $15 billion [10][14] - The Preecludia test addresses a significant unmet need in managing preeclampsia, with over 700,000 women presenting symptoms annually in the US [7][8] Company Strategy and Development Direction - The company is focused on transforming into an innovation-led biotech firm, emphasizing the development of its OBDS and DDS platforms [5][33] - Partnerships with major pharmaceutical companies are being pursued to enhance commercialization efforts for the Preecludia test and other products [8][19] - The company aims to reduce dependency on capital markets through strategic partnerships and asset divestitures [23][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the successful completion of the Preecludia validation study and its potential to transform patient management [6][25] - The company is committed to reducing its cash burn rate and enhancing its innovation pipeline, with multiple key catalysts anticipated in the near future [25][34] - The management highlighted the importance of partnerships in achieving commercialization goals and expanding market access [8][19] Other Important Information - The company settled a lawsuit with Natera through a cashless agreement, avoiding further legal costs [24] - The Avero affiliate laboratory operations continue to perform well, with potential divestiture being explored to generate non-dilutive capital [23] Q&A Session Summary Question: What is the status of the journal for Preecludia data submission? - The principal investigator intends to submit to a top-tier clinical journal [35][36] Question: Does the OpEx guidance include scaling up for the Preecludia launch? - Yes, it includes support work for commercialization and clinical utility studies [37][38] Question: When is the expected launch for Preecludia? - The launch is likely dependent on securing a commercial partner [39] Question: What is the status of Avero's revenue? - Avero's revenue is classified under discontinued operations as the assets are held for sale [40] Question: When can we expect updates on strategic alternatives for Avero? - Updates should be available this year depending on the decision to transact or retain the business [42] Question: How does the company's platform differentiate from competitors like Rani Therapeutics? - The company can use a variety of formulations, which provides a distinct advantage over Rani's technology [43] Question: Why focus on inflammatory bowel disease first? - The focus is on established drugs with known efficacy to minimize variability during early development [45] Question: What are the key endpoints for feasibility studies? - The goal is to achieve around 15% average bioavailability with a high tolerance for variability [49][50] Question: What factors influence the decision to divest Avero? - The preference is to divest, but strategic opportunities related to Preecludia may influence the decision [57]
Biora Therapeutics(BIOR) - 2021 Q2 - Earnings Call Presentation
2021-08-13 01:20
SECOND QUARTER 2021 – FINANCIAL RESULTS August 2021 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, fina ...
Biora Therapeutics(BIOR) - 2021 Q2 - Quarterly Report
2021-08-11 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share PROG The Nasdaq Global Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File ...
Biora Therapeutics(BIOR) - 2021 Q1 - Earnings Call Presentation
2021-05-14 04:31
| --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|--------------------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | First Quarter 2021 Financial Results | | | | | | | | | May 13, 2021 | | | 2 ©2021 Progenity, Inc. All rights reserved. 2 Forward Looking Statements This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial ...
Biora Therapeutics(BIOR) - 2021 Q1 - Earnings Call Transcript
2021-05-14 03:28
Financial Data and Key Metrics Changes - The company reported $25 million in revenues for Q1 2021, representing a 72% growth quarter-over-quarter and a 46% growth compared to Q1 2020 [55][48][56] - Average selling prices (ASPs) improved during the quarter, contributing to revenue growth [56][55] - The net loss for Q1 2021 was $32.3 million, which included $14.8 million of income from changes in fair value related to convertible notes [63][55] Business Line Data and Key Metrics Changes - The core molecular testing business achieved a revenue growth of 72% quarter-over-quarter, driven by improvements in ASPs and revenue cycle management [48][55] - The Preecludia test is expected to launch by Q4 2021, targeting a multi-billion dollar market opportunity [19][18] - The GI Precision Medicine pipeline is advancing, with significant progress in drug delivery systems and targeted therapeutics [21][20] Market Data and Key Metrics Changes - The company identified a $2 billion to $3 billion opportunity for the Preecludia test based on payer research indicating an understanding of the economic burden of preeclampsia [19][18] - The inflammatory bowel disease (IBD) market is estimated at $15 billion, with the company targeting this market with its drug delivery systems [23][21] Company Strategy and Development Direction - The company plans to focus on strategic biotech areas with high value generation potential, particularly in GI Precision Medicine and preeclampsia programs [7][8] - The strategy includes transforming established drugs with known efficacy and safety profiles to enhance treatment for GI localized diseases [34][33] - The company aims to achieve breakeven and profitability for its core business by the end of 2022 or early 2023 [61][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing catalysts such as the Preecludia validation study results and ongoing advancements in GI programs [66][66] - The company is focused on generating non-dilutive capital and reducing cash burn while maintaining appropriate funding for key R&D programs [61][66] Other Important Information - The company completed a private placement raising $25 million in gross proceeds, ending Q1 2021 with a cash balance of $65 million [65][63] - The company is on track to initiate a clinical pilot study for its PIL Dx program in the second half of the year [41][42] Q&A Session Summary Question: Can you provide details on core women's health volumes? - Management indicated that volumes were generally flat due to weather-related demand dynamics and ongoing sales channel transitions [70][69] Question: Can you elaborate on the Crohn's & Colitis funding? - The funding is a cost-sharing arrangement aimed at supporting studies for the drug delivery system (DDS) development [71][70] Question: What is the latest on Innatal 4 development? - The next catalyst for Innatal 4 is expected in Q3, with commercialization anticipated by the end of Q2 or beginning of Q3 next year [73][72] Question: What factors influenced gross margin and cost of goods? - The increase in Q1 COGS was attributed to stock-based compensation accruals, while COGS per test remained stable [76][75] Question: What is the status of the Preecludia sales force preparation? - The sales force is being trained and prepared for a targeted launch, with no significant ramp-up needed as existing capabilities are sufficient [83][82]
Biora Therapeutics(BIOR) - 2021 Q1 - Quarterly Report
2021-05-12 16:00
[PART I—FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The unaudited condensed consolidated financial statements for Q1 2021 show a **45.7%** revenue increase, narrowed operating loss, and a significant cash decrease, with a going concern warning [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$128.6 million** as of March 31, 2021, from **$154.4 million** at year-end 2020, driven by a **$26.8 million** reduction in cash, while total liabilities slightly decreased and stockholders' deficit widened Condensed Consolidated Balance Sheet Highlights (in thousands USD) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $65,276 | $92,076 | | Total current assets | $101,171 | $126,338 | | Total assets | $128,577 | $154,440 | | Total current liabilities | $80,062 | $72,670 | | Total liabilities | $254,084 | $261,434 | | Total stockholders' deficit | ($125,507) | ($106,994) | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2021 revenues increased to **$24.5 million** from **$16.8 million** in Q1 2020, achieving a **$2.3 million** gross profit, narrowing the operating loss to **$46.2 million**, but net loss widened to **$32.3 million** due to a prior-year tax benefit Q1 2021 vs. Q1 2020 Statement of Operations (in thousands USD, except per share data) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Revenues | $24,526 | $16,828 | | Gross Profit (Loss) | $2,292 | ($9,742) | | Loss from Operations | ($46,248) | ($52,526) | | Net Loss | ($32,264) | ($17,152) | | Net Loss Per Share | ($0.56) | ($3.43) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$48.6 million** in Q1 2021, partially offset by **$22.2 million** from financing, resulting in a **$26.8 million** net decrease in cash and equivalents Cash Flow Summary (in thousands USD) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($48,564) | ($30,886) | | Net cash used in investing activities | ($463) | ($1,094) | | Net cash provided by financing activities | $22,227 | $10,584 | | Net decrease in cash and cash equivalents | ($26,800) | ($21,396) | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes reveal a going concern warning due to insufficient cash, detail revenue recognition, payor concentration, convertible note terms, and significant legal contingencies including government settlements and patent litigation - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern for 12 months, as current cash of **$65.3 million** is not sufficient to fund planned expenditures without raising additional capital[20](index=20&type=chunk) Revenue by Payor Type (in thousands USD) | Payor Type | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Commercial third-party payors | $16,453 | $21,562 | | Government health benefit programs | $5,726 | ($6,143) | | Patient/laboratory distribution partners | $2,347 | $1,409 | | **Total revenues** | **$24,526** | **$16,828** | - The fair value of the derivative liability associated with the Convertible Notes decreased from **$18.4 million** to **$3.5 million** during the quarter, resulting in a non-cash gain of **$14.9 million**[84](index=84&type=chunk) - In February 2021, the company raised approximately **$25.0 million** through a private placement of 4,370,629 units, each consisting of one share of common stock and one warrant to purchase a share of common stock[129](index=129&type=chunk) - The company has significant legal contingencies, including remaining payments for government settlements, a **$12.0 million** remaining obligation to UnitedHealthcare, and a dispute with Anthem seeking recoupment of approximately **$27.4 million**[112](index=112&type=chunk)[114](index=114&type=chunk)[118](index=118&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a **45.7%** Q1 2021 revenue increase, impacted by a prior-year refund reserve, strategic shift to in-network contracts, and ongoing R&D, reiterating a going concern risk due to insufficient cash for the next 12 months [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Q1 2021 revenue increased by **$7.7 million (45.7%)** to **$24.5 million**, primarily due to a **$13.2 million** prior-year refund reserve, while cost of sales decreased and G&A expenses rose by **29.9%** - The primary driver for the **45.7%** year-over-year revenue increase was a **$13.2 million** refund reserve related to a DOJ settlement recorded in Q1 2020, which did not recur in Q1 2021[198](index=198&type=chunk) - Cost of sales decreased by **16.3%** primarily due to lower core test volumes, a reduction in indirect overhead, and lower royalty fees[200](index=200&type=chunk) - General and administrative expenses increased by **29.9%** due to higher salaries and personnel costs (**$2.1 million**), business insurance (**$1.5 million**), and reimbursement service costs (**$0.9 million**)[205](index=205&type=chunk) - A non-cash gain of **$14.9 million** was recognized due to the decrease in the fair value of the embedded derivative liability related to the Convertible Notes[208](index=208&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2021, the company held **$65.3 million** in cash, deemed insufficient for the next 12 months, raising substantial doubt about its going concern ability and necessitating further capital raises - The company does not expect its current cash and cash equivalents of **$65.3 million** to be sufficient to fund operations for at least 12 months from the financial statement issuance date[211](index=211&type=chunk)[213](index=213&type=chunk) Cash Flow Summary for Q1 2021 (in thousands USD) | Cash Flow Activity | Amount | | :--- | :--- | | Cash used in operating activities | ($48,564) | | Cash used in investing activities | ($463) | | Cash provided by financing activities | $22,227 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Progenity is exempt from providing quantitative and qualitative disclosures about market risk - Progenity is a smaller reporting company and is therefore not required to provide quantitative and qualitative disclosures about market risk[242](index=242&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2021 - Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[243](index=243&type=chunk) [PART II—OTHER INFORMATION](index=45&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) This section details significant legal matters, including **$49 million** in government settlement payments for past billing practices, ongoing patent infringement lawsuits, and a class-action lawsuit alleging misleading IPO statements - The company has entered into settlement agreements with the DOJ and 45 states to resolve investigations into legacy billing practices, with remaining payments of approximately **$5.1 million** due in 2021, **$6.9 million** in 2022, and **$0.2 million** in 2023[248](index=248&type=chunk)[252](index=252&type=chunk)[258](index=258&type=chunk) - The company is involved in ongoing patent infringement lawsuits filed by Natera, Inc. and Ravgen, Inc., and believes the claims are without merit[261](index=261&type=chunk)[262](index=262&type=chunk)[263](index=263&type=chunk) - A class-action lawsuit was filed against the company following its IPO, alleging that the registration statement contained false and misleading statements regarding overbilling of government payors and negative business trends[264](index=264&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include the ongoing impact of COVID-19, a history of financial losses, the critical need for additional capital to avoid going concern issues, potential declines in COVID-19 testing demand, and financial inflexibility due to **$171.5 million** in outstanding debt - The COVID-19 pandemic could continue to materially affect operations, disrupt the supply chain, and cause delays in preclinical and clinical trials[265](index=265&type=chunk)[267](index=267&type=chunk)[269](index=269&type=chunk) - The company has a history of losses and expects to need to raise additional capital to fund operations; failure to do so may require curtailing or ceasing operations[272](index=272&type=chunk)[276](index=276&type=chunk) - Future demand for COVID-19 testing is difficult to predict and may decrease as the pandemic subsides, potentially making the company's investment in this area less profitable[275](index=275&type=chunk) - As of March 31, 2021, the company had approximately **$171.5 million** of outstanding indebtedness, which may impair financial and operating flexibility[284](index=284&type=chunk) [Item 6. Exhibits](index=55&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed with the Form 10-Q, including the Form of Warrant, a Securities Purchase Agreement from February 2021, and officer certifications - Key exhibits filed with this report include the Securities Purchase Agreement dated February 22, 2021, and certifications from the principal executive and financial officers[298](index=298&type=chunk)
Biora Therapeutics(BIOR) - 2020 Q4 - Earnings Call Presentation
2021-03-19 10:19
progenity® 1 ©2020 Progenity, Inc. All rights reserved. 1 Business Update and Fourth Quarter and FY 2020 Financial Results March 18, 2021 2 ©2020 Progenity, Inc. All rights reserved. 2 Forward Looking Statements This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presen ...
Biora Therapeutics(BIOR) - 2020 Q4 - Earnings Call Transcript
2021-03-19 02:04
Progenity, Inc. (PROG) Q4 2020 Results Conference Call March 18, 2021 4:30 PM ET Company Participants Robert Uhl - Managing Director, Westwicke ICR Dr. Harry Stylli - Chairman and CEO Eric d’Esparbes - CFO Conference Call Participants Steven Mah - Piper Sandler Catherine Schulte - Baird Sung Ji Nam - BTIG Andrew Cooper - Raymond James Dan Leonard - Wells Fargo Operator Welcome to the Progenity’s Fourth Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker pr ...
Biora Therapeutics(BIOR) - 2020 Q4 - Annual Report
2021-03-17 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39334 PROGENITY, INC. (Exact name of Registrant as specified in its Charter) Delaware (State or other jurisdiction of incorporation o ...